Atlas FDA

AEROSET SYSTEM

FDA 510(k) clearance K980367 · decided 1998-04-01

Clearance details

K-number
K980367
Device name
AEROSET SYSTEM
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-01-29
Decision date
1998-04-01
Days to decision
62 days
Clearance type
Traditional
Product code
CGZ
Device class
2
Regulation number
862.1170
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinic recall (Z-0921-2018)Abbott Laboratories, Inc2018-01-18
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinic recall (Z-0922-2018)Abbott Laboratories, Inc2018-01-18
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clin recall (Z-0923-2018)Abbott Laboratories, Inc2018-01-18
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is recall (Z-2202-2015)Abbott Laboratories2015-07-22
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium recall (Z-1932-2015)Abbott Laboratories2015-06-27
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analy recall (Z-1725-2015)Abbott Laboratories2015-06-08
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06- recall (Z-2231-2008)Abbott Laboratories, Inc2008-09-11
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 6006 recall (Z-1166-2008)Abbott Laboratories, Inc2008-05-24
ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected recall (Z-0146-2008)Abbott Laboratories, Inc2007-11-07
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected recall (Z-0952-2007)Abbott Laboratories, Inc2007-06-19
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by recall (Z-0398-06)Abbott Laboratories, Inc2006-01-18
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. recall (Z-0008-06)Abbott Laboratories, Inc2005-10-06
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clini recall (Z-0010-06)Abbott Laboratories, Inc2005-10-06
AEROSET Analyzer, Systems Operation Manual. recall (Z-0016-05)Abbott Laboratories, Inc2004-10-09
ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporati recall (Z-1341-04)Abbott Laboratories, Inc2004-08-13
AEROSET System Software version 1.02ER000 recall (Z-0091-04)Abbott Laboratories, Inc2004-07-20
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Proce recall (Z-0818-04)Abbott Laboratories, Inc2004-07-20
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Divi recall (Z-0846-04)Abbott Laboratories, Inc2004-07-20
The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irv recall (Z-0263-04)Abbott Laboratories, Inc2003-12-24
Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irv recall (Z-1142-03)Abbott Laboratories, Inc2003-08-21
Aeroset Analyzer, item 9D05-01 recall (Z-0843-03)Abbott Laboratories, Inc2003-05-20
AEROSET Analyzer recall (Z-0844-03)Abbott Laboratories, Inc2003-05-20
AEROSET System External Waste Pump recall (Z-0796-03)Abbott Laboratories, Inc2003-05-09
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-0 recall (Z-0788-03)Abbott Laboratories, Inc2003-05-01
AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog nu recall (Z-0725-03)Abbott Laboratories, Inc2003-04-16

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
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ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30